NEW YORK, NY / ACCESSWIRE / October 10, 2017 / SeeThruEquity, a leading New York City based independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced that it has issued an update note on DelMar Pharmaceuticals, Inc. (DMPI).
The note is available here: DMPI October 2017 Update.
DelMar Pharmaceuticals, Inc. ("DelMar," Nasdaq CM: DMPI) is a clinical-stage biotechnology firm focused on the development and commercialization of new cancer therapies. DelMar specializes in the development of well-validated anti-cancer therapies in orphan drug indications where patients are failing modern targeted or biologic treatments. DelMar's lead compound is VAL-083 (dianhydrogalactitol). The company is conducting clinical trials with VAL-083 as a potential new treatment for refractory and front-line glioblastoma multiforme ("GBM"), the most common and aggressive form of brain cancer and other solid tumors. Delmar also recently announced a new IND for a Phase 2 study of VAL-083 in platinum-resistant ovarian cancer. VAL-083 is a first-in-class small molecule with a novel DNA-targeting agent that has been assessed in over 40 National Cancer Institute-sponsored clinical and pre-clinical trials showing the compound has potential for multiple cancers including brain, lungs, blood, and cervical. VAL-083 has also been approved in China for the treatment of lung cancer and chronic myeloid leukemia (CML).
Highlights from the note are as follows:
New Phase 2 Trial Expands Opportunity to Address GBM
DelMar's pivotal Phase 3 trial for VAL-083 for Avastin-resistant GBM is ongoing, with plans to investigate VAL-083 in up to 180 patients at 25 cities in the US. The enrollment process underway, and interim results expected in late 2018, with top-line results expected by mid-2019. Meanwhile, DMPI announced it has initiated a second Phase 2 clinical trial - in addition to the study already taking place in the US with MD Anderson - to investigate VAL-083 in combination with radiation for treatment of MGMT-unmethylated GBM. The trial will be funded by collaboration partner, Guangxi Wuzhou Pharmaceutical Group Co. Ltd., and will take place at Sun Yat-sen University Cancer Center (SYUCC) in Guangzhou, China. Positive data from the company's investigations of VAL-083 in combination with radiation to treat newly diagnosed MGMT-unmethylated GBM has the potential to establish VAL-083 as standard of care for the majority of GBM patients, and expand the market opportunity for VAL-083 significantly. DelMar management estimates that its annual market opportunity in GBM could be more than $1 billion, assuming positive results that could potentially position VAL-083 to become the standard of care for the 2/3 of GBM patients that exhibit high MGMT expression.
Non-GBM Markets Expand with New Trial for Ovarian Cancer
While much of our coverage has been focused on Delmar's mature clinical programs (VAL-083 for GBM), the company also continues to advance other indications for VAL-083 as well. On September 18, 2017, DelMar announced that the FDA has allowed an additional Investigational New Drug Application ("IND") to study its VAL-083 as a potential treatment for ovarian cancer. Over 20,000 women will be diagnosed with ovarian cancer in the US this year, according to the American Cancer Society. DelMar expects to initiate a Phase 1 / Phase 2 study in patients with Recurrent Platinum Resistant Ovarian Cancer ("VAL-083 REPROVe Trial"). The REPROVe Trial will study VAL-083 in platinum-resistant ovarian cancer, the single most important unmet need in ovarian cancer treatment today.
Updating Price Target to $5.20
We are updating the price target for DMPI $5.20 following recent clinical developments and financing activities. We now estimate that the company has pro forma cash and clinical trial funds on hand of $14.3mn, following a recent direct offering that raised gross proceeds of $10mn on September 22, 2017.
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About DelMar Pharmaceuticals, Inc.
DelMar Pharmaceuticals, Inc. was founded to develop and commercialize proven cancer therapies in new orphan drug indications where patients are failing or have become intolerable to modern targeted or biologic treatments. The Company's drug in development, VAL-083, is currently undergoing clinical trials in the U.S. as a potential treatment for refractory glioblastoma multiforme. VAL-083 has been extensively studied by U.S. National Cancer Institute, and is currently approved for the treatment of chronic myelogenous leukemia (CML) and lung cancer in China. Published pre-clinical and clinical data suggest that VAL-083 may be active against a range of tumor types via a novel mechanism of action that could provide improved treatment options for patients (www.Delmarpharma.com).
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